Adult Stem Cells
Adult Stem Cells

Adult Stem Cell Clinical Trial for patients with Critical Limb Ischemia (CLI) Caused by Severe Peripheral Arterial Disease (PAD)

CLINICAL TRIAL
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)

PURPOSE
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial disease (PAD).

OFFICIAL TITLE
MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects With Severe Peripheral Arterial Disease (PAD) (Clinical Trials Identifier: NCT01049919)

STUDY DESIGN & DATES

Phase III, Randomized, Double-Blind
Study Start Date: June 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

CONTACTS
Hillary Overholser
Phone: 574-371-1087
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

LOCATIONS

United States:

Arkansas
Central Arkansas Veterans Healthcare System, Little Rock
Contact: Sandra Brock (501-257-6906 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Mohammed Moursi, MD

California
University of California-Davis Medical Center, Sacramento
Contact: Christy Pifer (916-734-4156)
Principal Investigator: John R. Laird, MD

Florida
University of Miami, Miami
Contact: Lynne Sparling (305-243-7298 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Omaida Velazquez, MD

Georgia
Piedmont Hospital, Atlanta
Contact: Mihyang Kim, RN (404-605-2958 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Charles B Ross, MD

Indiana
Indiana University School of Medicine, Indianapolis
Contact: Kristen Wanczyk, RN (317-988-9548 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Michael P. Murphy, MD

Iowa
University of Iowa Hospitals and Clinics, Iowa City
Contact: Judith Pena-Quevedo, RN (319-353-8736 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Melhem J. Sharafuddin, MD

Kentucky
University of Louisville, Louisville
Contact: Shari Williams, RN (502-407-3259 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Marvin E. Morris, MD

Massachusetts
UMass Memorial Health Care, Worcester
Contact: Shauneen Valliere (508-856-1767 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Louis Messina, MD

Michigan
Spectrum Health, Grand Rapids
Contact: Jeanine Holen (616-391-5067 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Christopher M. Chambers, MD, PhD

New York
Weill Cornell Medical College / New York-Presbyterian Hospital, New York city
Contact: Ruchita Mehta (212-746-5949 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: John Karwowski, MD

Ohio
The Cleveland Clinic, Cleveland
Contact: Jennifer Seaber (216-445-8063 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Rebecca L. Kelso, MD

University Hospitals Case Medical Center, Cleveland
Contact: Lori Hammer (216-983-4719 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Vikram S Kashyap, MD, F.A.C.S.

Remington-Davis, Columbus
Contact: Jennifer M Botte, BS, RN (614-487-2560 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Lucy M Laperna, D.O., RVT, RPVI

Washington
Providence Sacred Heart Medical Center, Spokane
Contact: Claudia Flores (509-474-4306 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Joseph Davis, MD

Wisconsin
Aurora St. Luke's Medical Center, Milwaukee
Contact: Valerie Williams, RN, CCRC (414-649-6853 or This email address is being protected from spambots. You need JavaScript enabled to view it. )
Principal Investigator: Tanvir Bajwa, MD

INVESTIGATORS

Principal Investigator: Michael P. Murphy, MD Indiana University School of Medicine

ELIGIBILITY: INCLUSION CRITERIA

Unilateral or bilateral lower extremity ischemia due to advanced peripheral arterial disease

Non-candidates for surgical bypass or percutaneous angioplasty and stenting

Maximal medical therapy for critical limb ischemia

Minor tissue loss (Rutherford Category 5) or ischemic rest pain (Rutherford Category 4) with ABI ≤ 0.6, or TBI ≤ 0.4, or TcPO2 ≤ 50 mm Hg

Competent to give consent

No current malignancy or history of previous malignancy within the last five years, with the exception of adequately treated non-melanoma skin cancer (evidence of standard preventative cancer screenings required)

ELIGIBILITY: EXCLUSION CRITERIA

Major tissue loss (Rutherford Category 6)

Diabetics on oral or insulin therapy with active (or history of) proliferative retinopathy (evidence of retinal exam required)

Poorly controlled diabetes mellitus with HbA1C > 10% (evidence of HbA1C test required)

Uncompensated congestive heart failure (New York Heart Association Class IV) and/or other conditions that preclude general anesthesia

Myocardial infarction or stroke within last 90 days

Elevated liver function tests (AST or ALT more than twice normal upper limit)

Renal disease (creatinine > 2.5 mg/dl) or chronic hemodialysis

White blood cell count < 3,000/µL or > 15,000/µL, platelet count < 100,000/µL, or hematocrit < 32%

Topical growth hormone therapy within last 90 days, or injected growth hormone therapy within last 180 days

Disease of central nervous system and/or other conditions that impair cognitive function

Two or more episodes of pulmonary embolus with a documented DVT in index leg or history of DVT in index leg without evidence of clot resolution

Infection of index leg

Pregnant women (negative urine pregnancy test required)

Lower extremity venous disease with pitting edema in index leg

History of bone marrow disease prohibiting transplantation

History of non-cancer chemotherapy or radiation affecting bone marrow

Osteomyelitis in index leg

Existing HIV diagnosis

Organ transplant recipients

Known terminal disease process with life expectancy less than one year

Severe concomitant disease(s) or any additional condition(s) which the investigator feels constitute(s) criteria for exclusion of a particular subject

Amputation required within 30 days

Inclusion in any other clinical study that may affect the outcome of this study

Uncorrected stenosis(es) of greater than 50% in the common and/or external iliac artery and/or common femoral artery of the index leg

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Adult Stem Cells
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